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The QWIX Positioning Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:

• Mono or Bi-cortical osteotomies in the foot or hand (including Hallux Valgus treatment)
• Fractures management in the foot or hand -
• Fixation of bone fragments in long bones or small bones fractures -
• Arthrodesis in hand, foot or ankle surgery -

The size of the chosen screw should be adapted to the specific indication.

The QWIX® Positioning Screw is a cannulated fully threaded screw. It also has a self-tapping screw tip. It is provided in diameters 5.5 mm and 7.5 mm and in length from 30 mm to 80 mm for the 5.5 mm and from 40 mm to 120 mm for the 7.5 m. The QWIX® Positioning Screw is made from Titanium alloy (Ti-6Al-4V ELI).

The provided text describes a 510(k) premarket notification for the QWIX® Positioning Screw. This document focuses on demonstrating substantial equivalence to an existing predicate device rather than establishing new performance criteria through efficacy studies with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be fully provided from the given text.

Here's an analysis of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion	Reported Device Performance
   Mechanical Properties	"Mechanical tests have been carried out. Results have shown that the mechanical properties of the QWIX® Positioning Screw staples have similar to properties of predicate devices, such as Newdeal ICOS screws (K011821) and Synthes 7.3 screw (K962011)."
   Substantial Equivalence	"The new QWIX® Positioning Screws are substantially equivalent to the commercially marketed device, Stabilization Screw, K050346."

   Note: The document states "similar to properties" and "substantially equivalent" rather than specific quantitative acceptance criteria or numerical performance metrics. The 510(k) process is about demonstrating equivalence, not necessarily meeting a predefined performance target in the same way a de novo or PMA would require.

2. Sample size used for the test set and the data provenance:

   • No specific sample size for a "test set" (in the context of clinical or algorithmic performance evaluation) is mentioned.
   • The study referenced is "Mechanical tests," which typically involves material and component testing, not human or patient data. Therefore, data provenance relevant to clinical outcomes is not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. Ground truth in a clinical or diagnostic sense is not established for this type of submission. The comparison is mechanical properties against existing devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. There is no "test set" requiring expert adjudication in this context.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a bone fixation screw, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" or reference for the mechanical tests would be the established mechanical properties of the predicate devices (Newdeal ICOS screws (K011821) and Synthes 7.3 screw (K962011)) and relevant material standards. This is not "expert consensus, pathology, or outcomes data" in a clinical sense.

8. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established:

   • Not applicable.

Summary of what the document does provide:

• Device: QWIX® Positioning Screw, a cannulated fully threaded screw for bone fixation.
• Indicated Use: Fixation of bone fractures or bone reconstruction in the foot or hand, including osteotomies, Hallux Valgus treatment, fracture management, fixation of bone fragments, and arthrodesis.
• Basis for Approval: Substantial equivalence to predicate device Stabilization Screw, K050346.
• Supporting Evidence for Equivalence: Mechanical tests showing "similar" mechanical properties to other predicate devices (Newdeal ICOS screws K011821 and Synthes 7.3 screw K962011). The submission also asserts same intended use, materials, basic design, instructions for use, and manufacturing process as previously cleared devices.

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